Oncology Newsfeed

CMS Issues Drug Pricing Transparency Proposed Rule

According to a CMS statement, under the proposed rule, the price required to be posted would be for a typical course of treatment for an acute medication like an antibiotic, or a 30-day supply of medication for a chronic condition that is taken every month. The posting would take the form of a legible textual statement at the end of the ad, the agency said. The HHS Secretary would maintain a public list of drugs that were advertised in violation of this rule. CMS would provide an exception to the requirement to post prices for prescription drugs with list prices of less than $35 per month.

Read the proposed rule here.

CMS will accept comments on the proposed rule until Dec. 17, 2018.

ACCC policy staff is currently analyzing the proposed rule.

Posted 10/15/18

New Clinical Guideline Issued for Early-Stage Prostate Cancer Patients Treated with EBRT

CMS Acts to Support Georgia in Response to Hurricane Michael

Key administrative actions CMS is taking in response to the public health emergency declared in Georgia:

• Waivers for Hospitals, Healthcare Facilities, and Clinicians: CMS will be temporarily waiving or modifying certain Medicare, Medicaid, and CHIP requirements. The CMS Regional Offices will be granting other provider-specific requests for specific types of hospitals and other facilities in Georgia. These waivers work to provide continued access to care for beneficiaries. For more information, visit: www.cms.gov/emergency.
• Special Enrollment Opportunities for Individuals Impacted by the Hurricane: CMS has made special enrollment periods available for certain individuals seeking health plans offered through the Federal Health Insurance Exchange and all Medicare beneficiaries. This gives people impacted by the hurricane the opportunity to gain access to health coverage on the Exchange or change their Medicare health and prescription drug plans immediately if eligible for the special enrollment period. For more information, visit:

• https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/8-9-natural-disaster-SEP.pdf
• https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Past-Emergencies/Hurricanes-and-tropical-storms.html.

• Disaster Preparedness Toolkit for State Medicaid Agencies: CMS developed an inventory of Medicaid and CHIP flexibilities and authorities available to states in the event of a disaster. For more information and to access the toolkit, click here.  
• Dialysis Care: CMS is helping patients obtain access to critical life-saving services. The Kidney Community Emergency Response (KCER) program has been activated and is working with IPRO End Stage Renal Dialysis Network of the South Atlantic (NW 6) to assess the status of dialysis facilities in the potentially impacted areas related to generators, alternate water supplies, education and materials for patients, and more. They are also assisting patients who have evacuated ahead of the storm to receive dialysis services in the location to which they are evacuating. Patients have been educated to have an emergency supply kit on hand including important personal, medical, and insurance information; contact information for their facility; the ESRD NW hotline number; and contact information of those with whom they may stay or for out-of-state contacts in a water proof bag. They have also been instructed to have on hand supplies to follow a three-day emergency diet. The toll-free hotline for NW 6 is 1-800-524-7139 and the KCER hotline is 866-901-3773. Additional information is available on the NW website  or the KCER website. 
• Medical equipment and supplies replacements: CMS will temporarily suspend certain requirements necessary for Medicare beneficiaries who have lost or sustained damage to their durable medical equipment, prosthetics, orthotics, and supplies as a result of the hurricane. Medicare beneficiaries can contact 1-800-MEDICARE (1-800-633-4227) for assistance.
• Suspension of Enforcement Activities: CMS will suspend current survey and enforcement activities for healthcare facilities in the affected areas of Georgia, but will continue to investigate allegations of immediate threat to patient health and safety.
• Ensuring Access to Care in Medicare Advantage and Part D.  During a PHE, Medicare Advantage Organizations and Part D Plan sponsors must take steps to maintain access to covered benefits for beneficiaries in affected areas. These steps include allowing Part A/B and supplemental Part C plan benefits to be furnished at specified non-contracted facilities and waiving, in full, requirements for gatekeeper referrals where applicable.

CMS will continue to work with all geographic areas impacted by Hurricane Michael. Beneficiaries and providers of healthcare services that have been impacted are encouraged to seek help by visiting CMS’ emergency webpage.

Posted 10/11/18

CMS Announces Steps to Support Florida in Response to Hurricane Michael

On October 10, the Centers for Medicare & Medicaid Services (CMS) announced steps taken by the agency to support Florida in response to Hurricane Michael. The actions include temporarily waiving or modifying certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements; creating special enrollment opportunities for individuals to access healthcare immediately; and taking steps to ensure dialysis patients obtain critical life-saving services.

Below are key actions CMS is taking in response to the Public Health Emergency (PHE) declared in Florida:

• Waivers for Hospitals, Healthcare Facilities, and Clinicians: CMS will be temporarily waiving or modifying certain Medicare, Medicaid, and CHIP requirements. CMS will be issuing a number of waivers as necessary, which will be listed on the website below, and the CMS Regional Offices will be granting other provider-specific requests for specific types of hospitals and other facilities in Florida. These waivers work to provide continued access to care for beneficiaries. For more information on the waivers CMS will grant, visit the CMS website.

• Special Enrollment Opportunities for Individuals Impacted by the Hurricane: CMS has made special enrollment periods available for certain individuals seeking health plans offered through the Federal Health Insurance Exchange and all Medicare beneficiaries. This gives people impacted by the hurricane the opportunity to gain access to health coverage on the Exchange or change their Medicare health and prescription drug plans immediately if eligible for the special enrollment period. For more information on these special enrollment periods, visit:

  • https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/8-9-natural-disaster-SEP.pdf

  • https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Past-Emergencies/Hurricanes-and-tropical-storms.html.

• Disaster Preparedness Toolkit for State Medicaid Agencies: CMS developed an inventory of Medicaid and CHIP flexibilities and authorities available to states in the event of a disaster. For more information and to access the toolkit, visit the Medicaid website.

• Dialysis Care:  CMS is helping patients obtain access to critical services. The Kidney Community Emergency Response (KCER) program has been activated and is working with Quality Insights Renal Network 7, ESRD NW 7, to assess the status of dialysis facilities in the potentially impacted areas related to generators, alternate water supplies, education and materials for patients, and more. They are also assisting patients who have evacuated ahead of the storm to receive dialysis services in the location to which they are evacuating. Patients have been educated to have an emergency supply kit on hand including important personal, medical, and insurance information; contact information for their facility; the ESRD NW hotline number; and contact information of those with whom they may stay or for out-of-state contacts in a water proof bag. They have also been instructed to have on hand supplies to follow a three-day emergency diet. Additional information is available on the NW’s websites (1, 2, and 3) or the KCER website.

• Medical equipment and supplies replacements: CMS will temporarily suspend certain requirements necessary for Medicare beneficiaries who have lost or sustained damage to their durable medical equipment, prosthetics, orthotics, and supplies as a result of the hurricane. This will help to make sure that beneficiaries can continue to access the needed medical equipment and supplies they rely on each day. Medicare beneficiaries can contact 1-800-MEDICARE (1-800-633-4227) for assistance.

• Suspension of Enforcement Activities: CMS will suspend current survey and enforcement activities for healthcare facilities in the affected areas of Florida, but will continue to investigate allegations of immediate threat to patient health and safety.

• Ensuring Access to Care in Medicare Advantage and Part D.  During a PHE, Medicare Advantage Organizations and Part D Plan sponsors must take steps to maintain access to covered benefits for beneficiaries in affected areas. These steps include allowing Part A/B and supplemental Part C plan benefits to be furnished at specified non-contracted facilities and waiving, in full, requirements for gatekeeper referrals where applicable.

CMS will continue to work with all geographic areas impacted by Hurricane Michael. Beneficiaries and providers of healthcare services that have been impacted are encouraged to seek help by visiting CMS’ emergency webpage.

NCCN Releases New Guidelines for Neuroendocrine Tumors

FDA Expands Approval of HPV Vaccine to People Aged 27 to 45

MedPAC Suggests Expansion of DVP to Inpatient Setting

Association of Community Cancer Centers (ACCC) comments to the Drug Value Plan proposal included within the 2019 OPPS rule urge that:  

"Any policy solution to rein in drug costs must preserve patients’ access to – and ability to afford – quality cancer care and, relatedly, mitigate any impact on already reduced payment rates for cancer care providers." 

Further, ACCC requests that the agency ensure that any model based on Competitive Acquisition Program (CAP) authority is:

• voluntary for all participants,
• preserves patient access to treatment and provider flexibility, and
• promotes cost-efficiency through more effective distribution and delivery of drugs and biological rather than utilization management tools.

Nobel Prize in Medicine Awarded to Two Cancer Immunotherapy Researchers

The Nobel Assembly at Karolinska Institute announced on Monday, Oct. 1, the 2018 Nobel Prize in Physiology or Medicine was awarded to James P. Allison, PhD, of The University of Texas MD Anderson Cancer Center in Houston, and Tasuku Honjo, MD, PhD, Deputy Director-General and Distinguished Professor of Kyoto University Institute for Advanced Study in Japan, for their discovery of cancer therapy by inhibition of negative immune regulation.

Their work laid the foundation for a new class of cancer drugs, checkpoint inhibitors, and established a fourth pillar of cancer treatment—immunotherapy.

In a statement, the Nobel Assembly lauded the two Laureates for creating “an entirely new principle for cancer therapy.”

Read the Nobel Assembly statement.

Listen to Dr. Allison's remarks at a press briefing on Oct. 1 during the Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference.

Posted 10/2/18

HHS OIG Report Raises Concerns About Medicare Advantage Step Therapy

The Department of Health and Human Services (HHS) Office of Inspector General (OIG) has issued a report that raises concerns about the beneficiary impact of the Centers for Medicare & Medicaid Services’ (CMS) new “fail first” step therapy policy for Medicare Advantage (MA) beneficiaries beginning in 2019. The report's findings include:

• A “central concern” in the MA program is that plans have “potential incentives” to “inappropriately deny access to services and payment in an attempt to increase their own profit.”
• 75% of MA plans’ coverage or payment denials were overturned at the first level of appeal, and additional denials were overturned in later stages of appeal.
• Treatment disruptions and coverage delays that are already regularly taking place in the MA program will be exacerbated under the new “fail first” policy.
• Beneficiaries and providers appealed only one percent of denials by MA plans, which may be due to the “confusing and overwhelming” process for many beneficiaries. 
• MA plans’ inaccurate coverage denials are particularly difficult for the MA patient population, finding that treatment delays “may be especially burdensome for beneficiaries with urgent health conditions.”

FDA Approves NGS Test to Detect MRD in ALL and Myeloma

On September 28, 2018, the U.S. Food and Drug Administration announced that the agency is permitting marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a measure of the amount of cancer cells remaining in a person’s bone marrow.

MRD is a general measure of the amount of cancer in the body (tumor burden), specifically the number of cancer cells that remain in a person’s bone marrow, either during or after treatment. Measuring MRD provides a tool to detect very low levels of tumor burden. MRD is useful to evaluate in patients who have responded to therapy when their tumor burden is below what can be detected with standard methods. The detection of MRD is associated with recurrence of the disease in those patients.

Read details in the FDA announcement.

Posted 10/1/18